TinnitusNCT05434637
Somatosensory Tinnitus RCT
A study testing Physical Therapy, Sound-based Therapy and Combination Therapy in people with Tinnitus, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to learn more about a type of tinnitus (ringing in the ears) known as "somatosensory tinnitus." This type of tinnitus is suspected when the tinnitus perception changes following head and/or neck movements. This study is also exploring a possible way to treat somatosensory tinnitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Physical Therapy, Sound-based Therapy and Combination Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Constant, chronic tinnitus (6-months in duration)
- Bothersome tinnitus based on Tinnitus Functional Index (TFI) score and self-reported loudness
- Able to modulate tinnitus perception with head, neck, and/or jaw maneuvers
Who cannot join
- Middle ear pathology
- Not a candidate for physical therapy
- Injury to the temporomandibular area in past 3 months
- Active pathology in the orofacial region
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
Sarah Theodoroff, PhD, (503) 220-8262 ext. 51948, Sarah.Theodoroff@va.gov
Sarah Theodoroff, PhD
About this study
Official title: Developing Tools and a Care Path for Somatosensory Tinnitus
The purpose of this study is to learn more about a type of tinnitus (ringing in the ears) known as "somatosensory tinnitus." This type of tinnitus is suspected when the tinnitus perception changes following head and/or neck movements. This study is also exploring a possible way to treat somatosensory tinnitus.
Read the detailed description
The purpose of this study is to: (1) develop a screening tool for somatosensory tinnitus and (2) perform a randomized clinical trial comparing different treatment approaches for somatosensory tinnitus. The investigators want to find out if individualized physical therapy, alone or in combination with audiology-based sound therapy, is beneficial for treating somatosensory tinnitus.
- Conditions
- Tinnitus
- Being tested
- Physical Therapy, Sound-based Therapy, Combination Therapy
- Keywords
- Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Also called Individualized Physiotherapy
Individuals randomized to this intervention will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.
Sound-based TherapyOther
Also called Audiology Therapy
Individuals randomized to this intervention will receive sound-based therapy, consistent with an audiology-based standard of care treatment.
Combination TherapyOther
Also called Physical Therapy + Audiology Therapy
Individuals randomized to this intervention will receive both individualized physical therapy and sound-based therapy.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Physiotherapy | Experimental | Individuals randomized to this group will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home. Receives: Other: Physical Therapy |
| Sound-based Therapy | Active comparator | Individuals randomized to this group will receive sound-based therapy, consistent with an audiology-based standard of care treatment. Receives: Other: Sound-based Therapy |
| Combination Therapy | Experimental | Individuals randomized to this group will receive both individualized physical therapy and sound-based therapy. Receives: Other: Combination Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tinnitus Functional Index (TFI) Score
The Tinnitus Functional Index (TFI) is a 25-item questionnaire that evaluates treatment responsiveness (i.e., changes in functional effects of tinnitus over time). Total possible score ranges from 0-to-100 (scores >25 indicate tinnitus is a significant problem).
Measured: Measured at at baseline; 8 and 12 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Nov 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sarah Theodoroff, PhD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434637
- Sponsor's protocol ID
- C3924-R
- Status last verified
- Aug 2026
- First submitted
- 22 Jun 2022
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Tools and a Care Path for Somatosensory Tinnitus
- ClinicalTrials.gov ID
- NCT05434637
- Acronym / sponsor ID
- C3924-R
- Conditions
- Tinnitus
- Keywords
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn more about a type of tinnitus (ringing in the ears) known as "somatosensory tinnitus." This type of tinnitus is suspected when the tinnitus perception changes following head and/or neck movements. This study is also exploring a possible way to treat somatosensory tinnitus.
Detailed description
The purpose of this study is to: (1) develop a screening tool for somatosensory tinnitus and (2) perform a randomized clinical trial comparing different treatment approaches for somatosensory tinnitus. The investigators want to find out if individualized physical therapy, alone or in combination with audiology-based sound therapy, is beneficial for treating somatosensory tinnitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individualized Physiotherapy | Experimental | Other: Physical TherapyIndividuals randomized to this group will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home. |
| Sound-based Therapy | Active comparator | Other: Sound-based TherapyIndividuals randomized to this group will receive sound-based therapy, consistent with an audiology-based standard of care treatment. |
| Combination Therapy | Experimental | Other: Combination TherapyIndividuals randomized to this group will receive both individualized physical therapy and sound-based therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Constant, chronic tinnitus (6-months in duration)
- Bothersome tinnitus based on Tinnitus Functional Index (TFI) score and self-reported loudness
- Able to modulate tinnitus perception with head, neck, and/or jaw maneuvers
Key exclusion criteria (4 listed)
- Middle ear pathology
- Not a candidate for physical therapy
- Injury to the temporomandibular area in past 3 months
- Active pathology in the orofacial region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyAlso: Individualized PhysiotherapyIndividuals randomized to this intervention will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home. | Other | Individualized Physiotherapy |
| Sound-based TherapyAlso: Audiology TherapyIndividuals randomized to this intervention will receive sound-based therapy, consistent with an audiology-based standard of care treatment. | Other | Sound-based Therapy |
| Combination TherapyAlso: Physical Therapy + Audiology TherapyIndividuals randomized to this intervention will receive both individualized physical therapy and sound-based therapy. | Other | Combination Therapy |
Primary outcome
Change in Tinnitus Functional Index (TFI) Score
Time frame: Measured at at baseline; 8 and 12 weeks post-randomization
The Tinnitus Functional Index (TFI) is a 25-item questionnaire that evaluates treatment responsiveness (i.e., changes in functional effects of tinnitus over time). Total possible score ranges from 0-to-100 (scores >25 indicate tinnitus is a significant problem).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Theodoroff, PhD principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy, Sound-based Therapy and Combination Therapy in people with Tinnitus, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Theodoroff, PhD ((503) 220-8262 ext. 51948, Sarah.Theodoroff@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tinnitus Functional Index (TFI) Score (time frame: Measured at at baseline; 8 and 12 weeks post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.